Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228

Celgene

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell; Prostatic Neoplasms

Treatments: Drug: FK228 (romidepsin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00106301

FJ-228-0007

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of extended treatment with FK228 in patients with metastatic renal cell carcinoma or hormone refractory prostate cancer who have at least demonstrated stable disease on prior Fujisawa sponsored FK228 clinical trials.

Full description

This is a Phase II, non-randomized, open-label, single arm, continuation trial.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has completed 6 cycles of therapy in a prior Fujisawa-sponsored FK228 clinical trial;
• Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Fujisawa-sponsored FK228 clinical trial;
• Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Fujisawa-sponsored FK228 clinical trial.

Exclusion criteria

• Patient has been on a prior Fujisawa-sponsored FK228 clinical trial, left the trial and then received alternative anti-neoplastic therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

FK228 (romidepsin)

Experimental group

Description:

romidepsin

Treatment:

Drug: FK228 (romidepsin)